G-BA decisions from 6 June 2024

Here are the G-BA decisions from the G-BA meeting held on 6 June 2024 on the early benefit assessments of Prevymis, Ebglyss, Takhzyro, Rubraca, Imfinzi, Brukinsa, and Praluent. Nearly all of them were negative!

A complete database of all previous G-BA resolutions is available upon request.

  • ​Prevymis (letermovir)
    • CMV reactivation/disease, prophylaxis after stem cell transplantation; re-assessment of an orphan drug after exceeding the €30 mn threshold – Hint of not-quantifiable additional benefit
    • CMV disease, prophylaxis after kidney transplantation; new indication – Additional benefit not proven
  • Ebglyss (lebrikizumab); Atopic dermatitis, patients aged ≥ 12 years – Additional benefit not proven
  • Takhzyro (lanadelumab); new indication: hereditary angioedema, prophylaxis, patients aged 2 to < 12 years – orphan drug, annual sales exceeding €30mn – Additional benefit not proven
  • Rubraca (rucaparib); new indication: ovarian cancer, fallopian tube cancer or primary peritoneal cancer, maintenance therapy after first-line therapy – Additional benefit not proven
  • Imfinzi (durvalumab); new indication: hepatocellular carcinoma, first line, monotherapy – Additional benefit not proven in both subgroups
  • Brukinsa (zanubrutinib); new indication: follicular lymphoma, after ≥ 2 previous therapies, in combination with obinutuzumab – Additional benefit not proven
  • Praluent (alirocumab); new indication: hypercholesterolemia, patients aged ≥ 8 years to 17 years) – Additional benefit not proven in both subgroups

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